CancerPhase 1NCT02552953
A Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
A Phase 1 study testing CYC065 in people with Cancer, run by Cyclacel Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This is an open-label, single arm, dose escalation study in patients with advanced cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CYC065
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2015to 25 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- 18 years or older
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- Evaluable disease
- Adequate organ functions
Show all 11Show fewer
- 4 weeks from prior chemotherapy ( 6 weeks for mitomycin C and nitrosourea) , immunotherapy, investigational anti-cancer therapy, radiation therapy; and have recovered from prior toxicities
- At least 4 weeks from major surgery
- Agree to practice effective contraception
- Agree to follow protocol required evaluations
- Ability to understand and willingness to sign the informed consent form
Who cannot join
- Previously untreated CNS metastasis or progressive CNS metastasis
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating women
- Known to be HIV-positive
- Known active hepatitis B and/or hepatitis C infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Read the detailed description
This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.
- Conditions
- Cancer
- Being tested
- CYC065
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYC065Drug
| Study group | Role | What they receive |
|---|---|---|
| CYC065 - 4 hour infusion (Part 1 completed) | Experimental | CYC065 will be administered by 4 -hour infusion every 3 weeks. Receives: Drug: CYC065 |
| CYC065 - 1 hour infusion (Part 2 - ongoing) | Experimental | CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks Receives: Drug: CYC065 |
| CYC065 - Oral (Part 3 - ongoing) | Experimental | CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks Receives: Drug: CYC065 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who experience dose-limiting toxicities
Measured: cycle 1(each cycle is 21 -28 days)
Secondary outcomes (3)
Plasma concentrations
Measured: cycle 1(each cycle is 21 -28 days)
Half-life of CYC065
Measured: cycle 1(each cycle is 21 -28 days)
changes in certain protein levels in peripheral white blood cells by western blots
Measured: cycle 1(each cycle is 21 -28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start28 Sep 2015
- Primary completion4 Oct 2022
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoffrey Shapiro, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552953
- Sponsor's protocol ID
- CYC065-01
- Status last verified
- May 2024
- First submitted
- 11 Sep 2015
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacologic Study of CYC065, a Cyclin Dependent Kinase Inhibitor, in Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT02552953
- Acronym / sponsor ID
- CYC065-01
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cyclacel Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2015 (actual)
- Primary completion
- 4 Oct 2022 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 17 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single arm, dose escalation study in patients with advanced cancers.
Detailed description
This is an open-label, single arm, dose escalation study in patients with advanced cancers. Treatment will be administered on an outpatient basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CYC065 - 4 hour infusion (Part 1 completed) | Experimental | Drug: CYC065CYC065 will be administered by 4 -hour infusion every 3 weeks. |
| CYC065 - 1 hour infusion (Part 2 - ongoing) | Experimental | Drug: CYC065CYC065 will be administered by 1 - hour infusion on Days 1, 2, 8, and 9 every 3 weeks |
| CYC065 - Oral (Part 3 - ongoing) | Experimental | Drug: CYC065CYC065 will be administered orally on Days 1, 2, 8 and 9 every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
- 18 years or older
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- Evaluable disease
Key exclusion criteria (6 listed)
- Previously untreated CNS metastasis or progressive CNS metastasis
- Currently receiving radiotherapy, biological therapy, or any other investigational agents
- Uncontrolled intercurrent illness
- Pregnant or lactating women
- Known to be HIV-positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYC065 | Drug | CYC065 - 1 hour infusion (Part 2 - ongoing), CYC065 - 4 hour infusion (Part 1 completed), CYC065 - Oral (Part 3 - ongoing) |
Primary outcome
Number of patients who experience dose-limiting toxicities
Time frame: cycle 1(each cycle is 21 -28 days)
3 secondary outcomes
Plasma concentrations
Time frame: cycle 1(each cycle is 21 -28 days)
Half-life of CYC065
Time frame: cycle 1(each cycle is 21 -28 days)
changes in certain protein levels in peripheral white blood cells by western blots
Time frame: cycle 1(each cycle is 21 -28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoffrey Shapiro, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYC065 in people with Cancer, run by Cyclacel Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who experience dose-limiting toxicities (time frame: cycle 1(each cycle is 21 -28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.